B.P.L.: Accelerated validation process with maximum cost-efficiency

B.P.L.: Accelerated validation process with maximum cost-efficiency

QbD client Bio Pharma Logistics is specialised in (bio) pharmaceutical shipments and clinical trials, warehousing, packaging and several added value services. Bio Pharma Logistics offers its services through a vast network of own offices and carefully selected agents and they are active in more than 124 countries worldwide. They urgently needed to validate their Quality Management System, which for instance supports the tracking and tracing of global shipments. These sensitive transactions had to comply with international regulations and safety & privacy requirements.

Three challenges

Bio Pharma Logistics needed to get a clear view on the – unexpectedly – wide scope of requirements that the validation of their IT system was to fulfil.

The deadline was tight: the whole validation process should be completed ASAP.

The unexpectedly wide scope and its complexity required finding the right balance between a high level of service and maximum cost-efficiency.

The solution: international QbD teamwork

To meet all three challenges QbD Belgium and QbD Mexico set up a joint taskforce and a smooth interface with the client. The Bio Pharma Logistics team is French-speaking. They were serviced in the front line by a familiar contact person: QbD Belgium consultant Sven Mus. He followed the project closely and reported in English, French and Dutch. One of the 2 Mexican project managers was Moises Anton who contributed throughout the project.

The added value of an international perspective

At QbD Mexico, Moises Anton’s task in the Bio Pharma Logistics project was to design the validation strategy, the validation plan, the elaboration and execution of the qualification protocols (IQ, OQ and PQ).

Moises Anton: “The requirements to comply with a validation of a computerized system are quite comprehensive. My work as a consultant, together with the team of QbD Belgium, was to guide the client step by step to meet the objectives set. Participating in this project was of great importance to me. It allowed me to interact and share points of view on an international level, both with colleagues from QBD Belgium and people at Bio Pharma Logistics.”

Working together with an international team offers added value. Each country contributes with a specific point of view. This synergy leads to good results in meeting complex and time-sensitive requirements.

24/7 Mexican support for speedy delivery

The whole validation project required more steps than expected. It included risk assessment, planning, technical, validation plan, documentation, testing, … etc. It also involved compliance to a wide set of international regulations and requirements concerning safety and privacy.

Dimitri Bettoni, CEO at Bio Pharma Logistics confirms: “Along the way the project proved more complex and layered than anticipated. Still, we rapidly needed a solution. QbD sped up the process by involving their Mexican colleagues. Follow-up was taken care of by our regular Belgian contacts and a Mexican project manager who spoke our language.”

José de Colsa: “The back-up from the Mexican team proved invaluable to move ahead fast. I can imagine the client thinking at the start: ‘Do these Mexican guys know what this is all about?’ On the final customer satisfaction evaluation, we received a quite pleasing answer: ‘Excellent job, timely performance and great knowledge.”

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